Insulin glulisine Pregnancy and Breastfeeding Warnings

Insulin glulisine is also known as: Apidra, Apidra Solostar

Insulin glulisine Pregnancy Warnings

Insulin glulisine given to animals throughout pregnancy at subcutaneous doses up to 10 units/kg once daily (an exposure 2 times the average human dose based on body surface area comparison) did not have any remarkable toxic effects on embryo-fetal development. Adverse effects on embryo-fetal development were only seen at maternal toxic dose levels inducing hypoglycemia. There are no controlled data in human pregnancy. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. Careful monitoring of glucose control is essential. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Insulin glulisine should only be used if the benefit outweighs the risk to the developing fetus.

Insulin glulisine Breastfeeding Warnings

Caution is recommended Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown. The manufacturer states that the use of insulin glulisine is compatible with breastfeeding, but lactating diabetic women may require insulin dose adjustments.

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